Study of Epratuzumab in Systemic Lupus Erythematosus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00382837|
Recruitment Status : Withdrawn
First Posted : October 2, 2006
Last Update Posted : May 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Drug: Epratuzumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Multi-Center, OpenLabel, Follow-Up Study to Assess the Safety & Efficacy of Epratuzumab in Patients With Acute Severe SLE Flares Excluding the Renal or Neurologic Systems|
|Study Start Date :||January 2007|
- The primary objective is to continue to gather long term safety data on patients with moderate to severe flaring SLE.
- To continue to assess the efficacy and tolerability of epratuzumab;
- To continue to monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
- To continue to assess epratuzumab on Health-related quality of life in lupus patients;
- To continue to assess disease status as reported by the patient and physician.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00382837
|Study Director:||Anna Barry||UCB Pharma|